FDA MedWatch - Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension by Plastikon Healthcare

Recall - Due to Microbial Contamination

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension by Plastikon Healthcare:  Recall - Due to Microbial Contamination AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy, Gastroenterology ISSUE: Plastikon Healthcare, LLC is updating the recall initiated on June 3, 2022. The recall has been expanded to include Lot 20076A of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL Oral Suspension. This lot has been added to the current recall based on updated microorganism speciation data from third-party testing. The updated recall includes one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, twelve (12) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL Oral Suspension, and two (2) lots of Magnesium Hydroxide 2400 mg/Aluminum Hydroxide 2400 mg/Simethicone 240 mg per 30 mL Oral Suspension. The products are being recalled due to microbial contamination. Risk Statement: Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention. Patients with compromised immune systems, such as patients in hospitals and nursing homes, have a higher probability of developing potentially life-threatening infections after taking a contaminated product. To date, Plastikon Healthcare has not received any reports of adverse events or injuries related to this recall. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The products being recalled are used for treat acid indigestion, heartburn, sour stomach and upset stomach due to these symptoms. RECOMMENDATIONS:  Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Anyone with an existing inventory of the lots which are being recalled should stop use and distribution, and quarantine immediately. Return all quarantined product to the place of purchase. For clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify patients regarding the recall. Patients with questions regarding this recall can contact the company. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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